Device Dossier

Pty Ltd - Equinoxe Humeral Liner - Reverse shoulder prosthesis cup

Device Dossier for Pty Ltd - Equinoxe Humeral Liner - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, Class III, sponsor Advita Ortho…

Intended purpose

The Equinoxe Humeral Liner is intended to replace the articular surface of the patient's humerus as part of a reverse shoulder joint replacement. The device is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The device is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Functional description

The Equinoxe Humeral Liner is made of UHMWPE and connects to the humeral stem via adapter and replaces the articular surface of the humerus as part of a reverse shoulder replacement.

TGA Public Summary